Label: UMCKA COLDCARE SUGAR FREE GRAPE- pelargonium sidoides syrup
- NDC Code(s): 53499-5794-5
- Packager: Schwabe North America, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated November 13, 2023
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- Active Ingredient
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Dosage and Administration
Directions
For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Shake well before each use.
Use only with enclosed dosage cup.
Adults & children 12 years of age and older: Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily.
Children 6-11 years of age: Take 1 teaspoon (tsp) (5mL) 3 times daily.
Children under 6 years of age: Consult a physician. - Indications & Usage
- Purpose
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Warnings
Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting, or rash, may be serious.
Consult a physician promptly.
Ask the Doctor
Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus).
Stope Use
Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or cough lasts more than 7 days or occurs with rash or persistent headache.
These could be signs of a serious condition.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UMCKA COLDCARE SUGAR FREE GRAPE
pelargonium sidoides syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5794 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X] in 120 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALCOHOL (UNII: 3K9958V90M) MALTODEXTRIN (UNII: 7CVR7L4A2D) WATER (UNII: 059QF0KO0R) CABBAGE (UNII: GW0W1Y9I97) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color Score Shape Size Flavor GRAPE (NATURAL GRAPE FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-5794-5 1 in 1 CARTON 09/01/2006 1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2006 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America 831153908 manufacture(53499-5794)
